Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy recall (Elekta, Inc.)
Medical deviceClass IIOngoing
Summary: Elekta, Inc. is recalling Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD Software Version: N/A Product Description: Digital Linear Accelerator Component: No. Reason: Due to a manufacturing issue and electrical grounding of systems.
What is being recalled
Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD Software Version: N/A Product Description: Digital Linear Accelerator Component: No
Why
Due to a manufacturing issue and electrical grounding of systems.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Worldwide
How to tell if yours is affected
Lot Code: 05060191071550 (NFB) Elekta Synergy 05060191071505 (FB) 05060191071543 (NFB) Elekta Infinity 05060191071512 (FB) 05060191071574 (NFB) Versa HD 05060191071529 (FB) 05060191071581 Harmony 05060191071604 Harmony Pro 07340201503461 Elekta Evo
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-1164-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | December 14, 2025 |
| Reported | February 4, 2026 |
| Company | Elekta, Inc. |
| Company location | Atlanta, GA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 5391 |
More recalls from Elekta, Inc. · all medical device recalls · recalls from December 2025